Clinical Trials Register

Summary
EudraCT Number:	2008-002121-36
Sponsor's Protocol Code Number:	MK0941-007
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2008-11-12
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2008-002121-36

A.3

Full title of the trial

A Phase IIb/III, Multicenter, Randomized, Double-Blind, Placebo-
Controlled Dose-Range Finding Clinical Trial of MK-0941 in
Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic
Control on Insulin.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

MK0941-007

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MERCK & CO., INC.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	MK0941
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MK0941
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Type 2 Diabetes Mellitus With Inadequate Glycemic
Control on Insulin

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10049746
E.1.2	Term	Insulin-requiring type II diabetes mellitus

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Objective: After 14 weeks, to assess the effect of treatment with MK-0941
compared with placebo on HbA1c when added to basal insulin.
Hypothesis: After 14 weeks, treatment with MK-0941 compared with placebo
provides greater reduction in HbA1c when added to basal insulin.
(2) Objective: To assess the safety and tolerability of MK-0941.

E.2.2

Secondary objectives of the trial

Objective: After 14 weeks, to assess the effect of treatment with MK-0941
compared with placebo on 2-hour postprandial glucose when added to basal insulin.
Hypothesis: After 14 weeks, treatment with MK-0941 compared with placebo
provides greater reduction in 2-hour postprandial glucose when added to basal
insulin.
(2) Objective: After 14 weeks, to assess the effect of treatment with MK-0941 compared with placebo on fasting plasma glucose when added to basal insulin.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

FARMACOGENETICA: Versione: Data: Titolo:MK0941-007 Obiettivi:

E.3

Principal inclusion criteria

Patient has type 2 diabetes mellitus (T2DM).
b. Patient is &#8805;21 and &#8804;70 years of age on day of signing informed consent.
c. Patient meets one of the following criteria as indicated by a "yes" answer to one of
the following:
Patient is currently on LANTUS insulin at a stable dose of &#8805;15 units/day, either
alone or in combination with metformin monotherapy at a dose of &#8805;1500 mg/day, for
at least 6 weeks and has a Visit 1/Screening Visit HbA1c &#8805;7.5% and &#8804;11.0%
OR
Patient is in 1 of the following 4 categories and based upon review of the patient’s
current diet, medical regimen, and Visit 1/Screening Visit HbA1c, patient is
considered by the investigator as likely to meet Visit 4/Week -2 inclusion criterion of
HbA1c &#8805;7.5% and &#8804;11.0% after a 6-week dose stable period on LANTUS (at a dose
of &#8805;15 units/day):
1) Patient is currently on any injectable insulin(s) (other than LANTUS alone) at a
stable dose of &#8805;15 units/day, either alone OR in combination with metformin
monotherapy at a dose of &#8805;1500 mg/day, for at least 6 weeks and has a
Visit 1/Screening Visit HbA1c &#8805;7.5% and &#8804;11.0%
2) Patient is currently on any injectable insulin(s) at a stable dose of &#8805;15 units/day in
combination with metformin monotherapy at a dose of <1500 mg/day OR another
oral monotherapy agent at any dose except a TZD (e.g., pioglitazone or
rosiglitazone), for at least 6 weeks and has a Visit 1/Screening Visit HbA1c
&#8805;7.0% and &#8804;10.5%

E.4

Principal exclusion criteria

a. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
OR
Patient is assessed by the investigator as possibly having type 1 diabetes confirmed
with a C-peptide <0.7 ng/mL (<0.23 nmol/L).
Note: Only patients assessed by the investigator as possibly having type 1 diabetes
should have C-peptide measured at Visit 1/Screening Visit.
b. Patient received more than 1 week of dosing of TZD therapy (e.g., pioglitazone or
rosiglitazone) or injectable incretin-based therapy (e.g., Byetta) within the prior 8
weeks.
c. Patient has had two or more episodes during their lifetime or more than one episode
within the past year that resulted in hypoglycemic seizures, comas or
unconsciousness.
Patients Requiring Specific Treatments
d. Hypersensitivity or contraindication to LANTUS insulin.
Patient is on a weight loss program and is not in the maintenance phase, or patient is
taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within
8 weeks of Visit 1/Screening Visit.
f. Patient has received treatment with an investigational drug within the prior 3 months
or is currently participating or planning to participate in another clinical trial.
g. Patient is on or likely to require treatment with warfarin or warfarin-like
anticoagulants, digoxin, or any other medication with a narrow therapeutic index
(refer to Appendix 6.4).
h. Patient is on or likely to require treatment with immunosuppressive/
immunomodulating agents (e.g., cyclosporine, methotrexate, etanercept) or patient is
on or likely to require treatment of &#8805;14 consecutive days or repeated courses of
pharmacologic doses of systemic (oral, injectable/parenteral) or ocular
corticosteroids, during the study.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint will be change from baseline in HbA1c after 14 weeks of
treatment.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

tra dosi

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-11-12.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	9
F.4.2	For a multinational trial
F.4.2.1	In the EEA	135
F.4.2.2	In the whole clinical trial	724

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-04-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-11-04

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2010-06-25

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